Medical Device Suppliers
Manage, collect and exchange accurate regulatory data required for global compliance and patient safety
The Market
Hospitals, GPOs and regulatory agencies are all demanding reliable product data from device manufacturers to ensure patient safety, reduce operational costs, and enhance the effectiveness of post‑market surveillance. As a result, global manufacturers now face the pressure, more than ever before, to deliver on their data quality and data syndication initiatives — or suffer the consequences of non-compliance.
Harmonizing data across global, regional, and country-level requirements adds cost and effort to medical device providers as the regulatory environment continues to evolve and becomes markedly more complex. Every country is developing their own directives and technical implementations for tracking and monitoring medical devices.
The Challenges
Medical Device Providers struggle to manage and exchange accurate data with trading partners while meeting the regulatory requirements for product identification, labeling, and traceability.Â
It’s a challenge to harmonize data in a centralized solution to ensure safe, accurate, and quick product recalls through complete product registration data submission to ensure patient safety.
Further, the regulatory environment continues to change with a diverse global standard becoming more complex and it’s difficult to adhere to global data standards and processes, such as GS1’s suite of standards requires effort to understand the impact of the standard and the best and most effective way to implement.
The Solution
Innovit understands how complex it is to manage and exchange the product data required to meet ever-evolving regulatory compliance deadlines as well as commercial demands from healthcare customers. The ever-evolving global standards environment and commercial requirements of healthcare providers create additional confusion and difficulty.
Take full control of your compliance processes with a purpose-built and proven solution for Global UDI compliance. Innovit’s purpose-built PIM simplifies the process of managing and exchanging validated regulatory data with hospitals, GPOs, and regulatory agencies around the world with one global scalable solution.
Clean and validate your data to ensure patient safety through delivery of high-quality data by partnering with the leader in global regulatory compliance and healthcare regulations. Leverage a single record of truth to easily share validated product data at a lower cost of ownership.
Innovit is more than an insurance policy for data accuracy and compliance! Trusted by B. Braun, 3M, J&J, Bio-Rad, Abbott, Zimmer, Ascensia, and many more, Innovit has successfully enabled our customers to successfully submit hundreds of thousands of items to regulatory agencies.
With over 20 years of international experience, we’ve helped 100+ medical device companies meet global compliance requirements and submitted hundreds of thousands of items to regulatory bodies, such as the FDA and EU Commission.
Partners in Healthcare
At Innovit, our commitment to the Healthcare industry is strengthened by our network of partners.  We collaborate with fellow thought leaders, industry experts, regulatory agencies, data pools, and global data standards bodies to help you solve the most challenging problems surrounding master data management and data compliance. Our global partners include: MedTech Europe, GS1 Global Healthcare, Atrify, USDM, HTG.
1WorldSync® is the leading provider of omnichannel product content solutions, enabling more than 14,000 companies in over 60 countries to empowers confident commerce and intelligent consumer purchasing decisions.
atrify is the cloud-based platform for product content for Fast-Moving-Consumer-Goods (FMCG), Foodservice, Healthcare, Travel Retail & DIY. With more than 20,000 companies in over 50 countries sharing content.
MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies.
Ready to get started?
Featured Resources
B. Braun Present at GS1 Digital Healthcare Summit
Learn How Mayo Clinic, the #1 hospital in America, and B. Braun, an innovative provider of medical products,
teamed up .
UDI Journey of Providing UDI Data for Hospitals and GPOs: Part One
As with most medical device companies, our journey into the world of UDI began with the introduction of new FDA requirements to publish product data. Understand a supplier’s perspective on the UDI Journey of Providing UDI data for hospitals and GPOs
TOP 12 THINGS TO PREPARE FOR YOUR UDI JOURNEY
Manufacturers distributing products multi-nationally need to address the rapidly approaching global UDI requirements in play in the U.S. and Europe.
Download our guide to learn the key steps for global UDI compliance.